TWILIGHT PEPPERMINT WITH VANILLA AND LAVENDER- potassium nitrate, sodium fluoride paste

Twilight Peppermint with Vanilla and Lavender by

Drug Labeling and Warnings

Twilight Peppermint with Vanilla and Lavender by is a Otc medication manufactured, distributed, or labeled by Smiletwice, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Potassium Nitrate 5%
Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Aids in prevention of dental cavities.

Warnings

When using this product,

if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Ascorbyl Phosphate (Vitamin C),
Retinyl Palmitate (Vitamin A),Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

Package Labeling:

INGREDIENTS AND APPEARANCE

TWILIGHT PEPPERMINT WITH VANILLA AND LAVENDER 
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72164-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72164-000-01	96 g in 1 TUBE; Type 0: Not a Combination Product	05/18/2018
2	NDC: 72164-000-00	2 in 1 BOX	05/18/2018	12/31/2019
2		96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/18/2018

Labeler - Smiletwice, Inc. (117404286)